What Does it Mean if FDA Enforcement is on the Decline?

FDA, safety alert, recalls

The U.S. Food and Drug Administration (FDA) performs a vital function for the consumer by regulating and enforcing safety measures for food, medical devices, and pharmaceutical products.  A recent study funded by Science Magazine suggests that the federal agency has been considerably less active in recent years.

Is the decline in official FDA activity a sign of federal deregulation? Or is it a sign that food and drugs are getting safer?

Understanding FDA Enforcement

There are specific standards that producers and manufacturers must meet for their products to be “FDA approved.” To ensure their standards, the FDA requires manufacturers to submit to inspections and perform postmarket studies, among other things.  In general, the FDA codifies regulations for:

  • Food products (except meat, dairy, and eggs)
  • Pharmaceutical drugs
  • Medical Devices

When producers fail to meet FDA standards, they can expect regulatory actions from the agency including warning letters, Official Action Indicated (OAI) reports, recalls, and injunctions.

Official Action Indicated Reports

OAI letters are precursors to warning letters or safety alerts.  Often following an unsatisfactory inspection result, OAI letters advise the manufacturer or producer that objectionable conditions exist and that they are subject to regulatory action or sanctions.

Warning Letters

Warning letters are a crucial tool the agency uses to keep the public informed about ineffective and potentially dangerous drugs, medical devices, and foods.  These letters demand action from food and drug producers. Also, they are published publicly online.  Science Magazine’s study says the agency has issued considerably fewer warning letters in recent years.

Untitled Letters

The least urgent of all communications from the FDA to a food or drug producer is an untitled letter.  Untitled letters communicate any concerns the agency may have that fall short of the threshold for formal warnings and sanctions.


Injunctions are a very rarely used enforcement action.  The FDA has the power to forcefully prevent the sale or distribution of unsafe or illegal products, but the agency rarely takes this step.

The vast majority of food or drug recalls are voluntary.  Manufacturers are usually fully aware of any failure on their own part to meet FDA regulations and will initiate a voluntary recall.  The FDA publishes, classifies, and tracks recalls until the threat to public safety dissipates.

Comparing Actions under Different Presidential Regimes

The study suggesting that regulatory actions for food and drug products have plummeted drew this conclusion by comparing actions under President Trump’s administration with actions taken under President Obama.  Here is what they found:

  • Warning letters fell by one-third, from 1,532 under Obama to 1,033 under Trump.
  • Warning letters from a specific sector in the agency, the Center for Devices and Radiological Health, dropped by two-thirds.
  • Letters from certain district offices specifically, Philadelphia, Florida, and New York also dropped by two-thirds.
  • The agency sent far fewer letters in the second year of the Trump administration than in the first year.
  • OAI letters have dropped by about half.
  • Injunctions fell from 35 to 26.
  • Untitled letters have declined sharply.

In publishing the findings of their study, Science Magazine quoted experts who believe there is an active agenda towards deregulation.  One expert stated,

“Industry may well take the message from this that the cop is not on the beat as often.”

The Areas in which FDA Regulation Did Not Decline

The agency’s Center for Drug Evaluation and Research (CDER) reviews and approves new pharmaceutical drugs.  It also polices drugs in the marketplace for safety and effectiveness.  Regulatory action actually increased under the current administration.  Currently, 188 warning letters are on record. This is in contrast to the 116 in the most recent comparable period under the previous administration.

As the opioid crisis in America has come to a head, this sector of the agency has been busier than ever before.  Medicine made overseas in India and China have seen consistently growing market shares among considerable concerns about quality and safety.  As a result, CDER has been very active in issuing warnings about drugs of foreign manufacture.

What does the FDA Say about its Regulation Statistics?

Since Science Magazine compiled data in the study from the agency’s own publicly available records, the FDA did not dispute the statistics.   However, the agency pointed out that not all actions they take are publicly visible.  Reporting numbers of warning letters or recalls does not present an accurate or complete picture of the work the agency does, according to their statement.

Actions that are not available to the public, and can remove the need for warning letters or public action, include:

  • Follow-up inspections
  • Meetings with companies
  • Threatening mandatory recalls
  • Coordination with European regulators
  • A new voluntary improvement pilot program for device makers

Scott Gottlieb, the first FDA commissioner in the Trump Administration denied the implications in the study.  Furthermore, his response makes it clear that he does not find it appropriate to impose a political agenda on the actions of the agency in recent years.

The former director cited more robust enforcement communications during his tenure for vaping, dietary supplements, stem cells, homeopathy, opioids, and generic drugs.  In the end, he argued the public should not read too much into the results of the study because warning letters and publicly available regulatory actions are not perfect enforcement tactics.  Supposedly, comparing straight numbers does not present an accurate picture of the agency’s enforcement activities or the effectiveness thereof.

What Does this Mean for the Consumer?

Fewer regulation actions could either mean food and drug producers are complying with FDA regulations at an extremely high rate.  Therefore, they are simply not giving the agency opportunity to issue enforcement actions.  At least, that seems to be what the agency’s leaders suggest.

On the other hand, the mice will play when the cat’s away.  Perhaps the historic government shutdown may also provide some explanation for the declining number of enforcement actions, and the public can expect a flood of FDA recalls and safety warnings as malfeasance comes to light throughout the coming months.

Talk to Drug and Device Watch about your Rights

Regardless of any FDA approval status or regulations, Americans have rights.  When you experience harm from food, a pharmaceutical drug, or a medical device, your rights may be violated.

If you are dealing with an injury or illness from an FDA-regulated product, you certainly have a right to hold the at-fault party accountable.  The at-fault party – manufacturer, producer, or distributor – is responsible for the cost of your harm. This includes medical bills and compensation for pain and suffering.

To find out more about your legal rights, contact Drug and Device Watch to talk to an attorney about your concerns.  Call 1-888-458-6825. You can also request a free legal consultation online via our contact form.